MRI-Guided Dynamic Support System for Scoliosis Correction | NCT07246122

Studies
MRI-Guided Dynamic Support System for Scoliosis Correction

NCT07246122

Sponsor

Chinese University of Hong Kong

Status

Recruiting

Last Update Posted

Nov 24, 2025Actual

Enrollment

10Estimated

Phase

Not Applicable

Conditions

Adolescent Idiopathic Scoliosis

Interventions

MRI-guided Dynamic Support System

Countries

Hong Kong

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 27, 2023Actual

Primary Completion Date

Dec 31, 2027Estimated

Completion Date

Dec 31, 2027Estimated

First Submitted Date

Jul 29, 2025

First Submission Date that Met QC Criteria

Nov 20, 2025

First Posted Date

Nov 24, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 20, 2025

Last Update Posted Date

Nov 24, 2025Actual

Name	Class
The Hong Kong Polytechnic University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This prospective pilot study evaluates the feasibility and effectiveness of an MRI-guided dynamic support system (MRI-DSS) for rapid, quantitative correction of adolescent idiopathic scoliosis (AIS). The system uses MRI-compatible air padding supports and programmable pneumatic control to apply and adjust corrective forces in real time. AIS patients underwent MRI-guided bracing, with Cobb angles and biomechanical parameters measured at each pressure level.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AIS bracing group	Experimental	Moderate AIS patients wearing customized MRI compatible soft brace, supine position lie in the MRI device	Device: MRI-guided Dynamic Support System

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MRI-guided Dynamic Support System	Device	MRI-compatible pneumatic support system with customized padding inserted into the brace, used for image-guided adjustment of corrective pressure during MRI scanning

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Cobb angle	degrees measured by MRI	baseline
Time to achieve target correction	measured in minutes	immediately after the intervention

Secondary Outcomes

Measure	Description	Time Frame
Contact area and force distribution	measured by 3D MRI reconstruction	immediately after the intervention

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age: 10-16 years
Diagnosis: Adolescent idiopathic scoliosis (Cobb angle 10-25°)
No prior spinal surgery or other orthopedic conditions
Able to provide informed consent
Risser sign 0-5

Exclusion Criteria:

Age <10 or >16 years
Cobb angle <10° or >25°
History of spinal surgery or other spine disorders
Contraindications to MRI

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

16 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Raymond Tong, PhD	Contact	39438454		kytong@cuhk.edu.hk
Joanne Yip, PhD	Contact	27664848		joanne.yip@polyu.edu.hk

Overall Officials

Name	Affiliation	Role
Raymond Tong, PhD	Chinese University of Hong Kong	Principal Investigator
Joanne Yip, PhD	The Hong Kong Polytechnic University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Hong Kong Polytechnic University	Recruiting	Tsim Sha Tsui	Kowloon		Hong Kong

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012600	Scoliosis

Ancestor Terms

ID	Term
D013121	Spinal Curvatures
D013122	Spinal Diseases
D001847	Bone Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided